[Federal Register Volume 60, Number 17 (Thursday, January 26, 1995)]
[Proposed Rules]
[Page 5152]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-2006]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Chapter I
[Docket No. 95D-0014]
Draft Proposed Regulations on Quality Standards and Certification
Requirements for Mammography Facilities; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability of draft proposed regulations.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of draft proposed regulations prepared by the Center for
Devices and Radiological Health (CDRH) to implement the Mammography
Quality Standards Act of 1992 (MQSA). The drafts contain minimum
quality standards for mammography facilities in the following areas:
Personnel standards, medical outcomes audits, medical records and
mammography reports, quality assurance, mobile mammography,
accreditation bodies, implant imaging, mammography equipment,
variances, consumer complaint mechanism, and quality control.
DATES: Written comments by April 11, 1995.
ADDRESSES: Submit written requests for single copies of the draft
regulations to the Center for Devices and Radiological Health (HFZ-
240), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD
20850. Send two self-addressed adhesive labels to assist that office in
processing your requests. Submit written comments on the draft proposed
regulations to the Dockets Management Branch (HFA-305), Food and Drug
Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857.
Requests and comments should be identified with the docket number found
in brackets in the heading of this document. A copy of the draft
proposed regulations and received comments are available for public
examination in the Dockets Management Branch (address above) between 9
a.m. and 4 p.m., Monday through Friday.
FOR FURTHER INFORMATION CONTACT: Charles K. Showalter, Center for
Devices and Radiological Health, Center for Devices and Radiological
Health (HFZ-240), 9200 Corporate Blvd., Rockville, MD 20850, 301-594-
3311.
SUPPLEMENTARY INFORMATION: FDA is announcing the availability of draft
proposed regulations regarding quality standards and certification
requirements for mammography facilities in the following areas:
Personnel standards, medical outcomes audits, medical records and
mammography reports, quality assurance, mobile mammography,
accreditation bodies, implant imaging, mammography equipment,
variances, consumer complaint mechanism, and quality control. These
proposed regulations are being developed to implement the MQSA (Pub. L.
102-539), which was enacted to establish quality standards for
mammography. The MQSA requires that, to provide mammography services
legally after October 1, 1994, all facilities, except facilities of the
Department of Veterans Affairs, must be both accredited by an approved
accrediting body and certified by the Secretary of Health and Human
Services (the Secretary). The authority to approve accrediting bodies
and to certify facilities has been delegated by the Secretary to FDA.
Pursuant to authorization from Congress, FDA promulgated interim
regulations to ensure that mammography facilities meet minimum quality
standards. These regulations, which were published in the Federal
Register on December 21, 1993 (58 FR 67558 and 58 FR 67565), and
amended on September 30, 1994 (59 FR 49808), became effective on
October 1, 1994, and will remain in effect until final regulations are
promulgated.
FDA is currently developing proposed regulations for quality
standards in various subject areas, including the 11 areas referenced
above. Under the MQSA, FDA established a National Mammography Quality
Assurance Advisory Committee (NMQAAC) to advise the agency on the
appropriate level of quality standards for mammography facilities and
accrediting bodies. Advanced drafts of proposed regulations are
provided routinely to all members of the advisory committee for their
advice and recommendation, and periodic public meetings of the advisory
committee are being held.
An advisory committee meeting was held on January 23 through
January 25, 1995. The meeting was announced in the Federal Register of
December 21, 1994 (59 FR 65776). It was held at the Dupont Plaza Hotel,
Embassy Room, 1500 New Hampshire Ave. NW., Washington, D.C.
In order to gather additional information on these particular
topics, FDA decided to share the drafts of these proposed regulations
with certain individuals who were invited as guests to the January 23
through 25, 1995, advisory committee meeting to enable them to provide
comments at the meeting on the feasibility of efficient implementation
of these draft proposed standards by the radiology community. These
invited guests have particular expertise in one or more of the areas
addressed by the draft proposals. The agency is publishing this notice
in order to make the same draft documents available to the general
public.
Although all members of the general public will have an
opportunity to comment on the proposed regulations when they are
published in the spring of 1995, interested persons who wish to comment
on the draft proposals may submit written comments to the Dockets
Management Branch (address above) on or before April 11, 1995. Two
copies of any comments should be submitted, except that individuals may
submit one copy. Comments are to be identified with the docket number
found in brackets in the heading of this document. The draft proposed
regulations and comments received may be seen in the Dockets Management
Branch between 9 a.m. and 4 p.m., Monday through Friday.
FDA will consider any comments received in developing final
regulations.
Dated: January 23, 1995.
William K. Hubbard,
Interim Deputy Commissioner for Policy.
[FR Doc. 95-2006 Filed 1-23-95; 3:40 pm]
BILLING CODE 4160-01-F
